The MediLedger Project
Chronicled is working in collaboration with The LinkLab to pioneer an open industry architecture to meet the requirements of the DSCSA regulation for the pharmaceutical industry.
- The Drug Supply Chain Safety Act (DSCSA) goes into effect this year to improve drug security, but lacks controls to prevent counterfeits and protect patients.
By 2023 the law requires that all prescription drugs can be tracked and traced through the supply chain using an interoperable system. However, there is no defined interoperable system today.
The FDA is looking for the industry to develop their own solution. Existing solutions are designed to meet today’s regulation, but do not have interoperability.
We have brought together industry leading companies to establish vision and a path forward in two distinct areas:
How could a blockchain platform be established for the Pharma supply chain? How could it operate to maximize participation, and how can an open system architecture deliver a competitive market for companies to deliver services to industry?
We have identified industry’s requirements to meet track and trace compliance, as well as operate in a shared ecosystem. We are working to deliver solutions to demonstrate the value blockchain solutions can add to the existing solutions industry has today.
Our current focus:
2019 requires all saleable returns must verify that the serial number is authentic. We are building the interoperable system that can quickly identify originating manufacturer’s GTIN / serial numbers as authentic.
- Exception Management
As inventory is moved using serial numbers, industry needs a solution that can reconcile exceptions based on available data automatically.
- Interoperable DSCSA system
We know the future is a system that verifies and authenticates medicine with each transaction. Our blockchain solution will enable improved supply chain security: no illicit product can enter the trusted network, or if it tries it will be identified. Investigations and recalls will be fast and accurate.